Understanding US FDA Regulatory Affairs

8 December 2022 | Short Online Course

£495.00

1 day live online training | Starts 9:30 AM UK Time

Develop effective regulatory strategies when working with the FDA – Click Here to Download the Agenda

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Course Overview

 

To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.

 

This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.

Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Understand the FDA structure, history and terminology so you are better equipped to communicate and interact with reviewers
  • Gain practical skills to manage the FDA Investigational New Drug (INDs) process and ensure submission efficiency
  • Understand best practice to navigate the FDA Investigational New Drug Application (IND) process and ensure you have all the data needed
  • Examine the FDA regulatory processes and requirements for pharmaceuticals, biologics and advanced therapies
  • Gain top tips for interacting with the FDA to obtain information quickly and prevent submission delays
  • Learn best practice for getting a generic product approved, including biosimilars.

What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session
Download the Agenda

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Post Learning Implementation Plan (PLIP)

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

8 December | 180 mins | 9:30 AM UK

Overview of the US Food and Drug Administration (FDA)

  • Brief history of the FDA and Regulations and how we got to where we are  today
  • Review the FDA’s organisation by division

 

Examining the drug development regulations in the US

  • The drug development process in the US
  • Clinical trials and Investigational New Drug (INDs)
  • Discover who is involved in development and the types of INDs
  • Basic understanding of the IND content and timings
  • Defining the regulatory requirements for submitting an IND

 

FDA Meetings

  • Review the various FDA meetings (Type A, B and C)
  • Discuss meetings on Biosimilars
  • Office of Tissues and Advanced Therapies (OTAT) meetings
Session 2

8 December | 180 mins | 1:30 PM UK

Evaluation of FDA review options

Understanding the following FDA review options:

  • Fast track / Priority review / Accelerated review / Breakthrough status
  • OTAT and RMAT Process / Interact

 

Reviewing the NDA process /BLA Process

  • Defining full NDAs / BLA
  • Examining the NDA categories
  • Explaining abbreviated NDAs and 505 (b) (2)
  • Learn the requirements and processes for biologics and advanced therapies (Cell and Gene)

 

ANDA (Generics) and 351K (Biosimilars)

  • Review of key differences to EU
  • Overview of regulatory positions
  • US strategies for development

 

Additional Considerations

  • Change Control
  • Use of Agents
  • Master Files
  • OTC Monographs

Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

 

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.

 

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses on the EU and US, specifically looking at QbD, CMC regs and lifecycle management. Andrew has delivered multiple courses on FDA regulatory affairs, supporting professionals with their FDA submissions. He has delivered FDA regulatory courses on a range of products such as pharmaceuticals, biotech, cell and gene, generics and biosimilars.

This course is aimed at professionals who work in regulatory affairs and are involved in the approval of therapeutics in the US. These include: Regulatory Affairs Professionals | CMC Regulatory Professionals | Product Registration Personnel | Project Managers in Regulatory Affairs | Compliance Managers | Documentation Specialists | Quality Professionals and QPs.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Complete our contact form by following the link. Get in touch.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training